Kornimate/medical-research-clean huggingface dataset:
a single ascending dose study of daclatasvir (bms-790052) in hepatitis c virus infected subjects

Conditions: Chronic Hepatitis C

Summary: the primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis c infection


Eligibility criteria:
key inclusion criteria: * chronically infected with hepatitis c virus genotype 1 * treatment naive or treatment non-responders or treatment intolerant; and not co-infected with hiv or hepatitis b virus * hepatitis c virus rna viral load of ≥ 10\*5\* iu/ml * bmi 18 to 35 kg/m² key exclusion criteria: * any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with hepatitis c virus infection * major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
a study of rheumatoid arthritis treatment with enbrel in adult patient in outpatient department

Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis

Summary: this is an open-label, multicenter and observational study in china, which is designed to record the data of ra \& as patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. all eligible subjects agreed to be recruited in the study and can withdraw anytime if they choose so. patients with ra or as are typically managed by rheumatologists. as this study seeks to record the data of ra \& as patient in etanercept and evaluate the safety and efficacy of the treatment, patients will be recruited from rheumatic department. rheumatologist will be asked to build up the database for ra \& as patient surveillance prospectively in outpatient dept, which benefits for the patient treatment outcomes evaluation and clinical management.

the primary objective of this non-interventional study is to evaluate the safety of etanercept in chinese ra and as subjects. total of 600 subjects (300 ra subjects and 300 as subjects) will be enrolled in the study. if the true rate of an adverse event is no less than 0.5%, with sample size of 600 subjects, this study will have 95% probability to detect at least one occurrence of the adverse event. the study prematurely discontinued on january 15, 2013 due to slow enrollment and low adherence of etanercept. it should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis. * subject has accepted physician's prescription of etanercept in rheumatology department. * subject agreed to be enrolled in the observational study and sign the icd. * subject is≥18 years of age at the time of consent. * subject is willing and able to understand and complete questionnaires exclusion criteria: * presence of active or suspected latent infection including hiv, or any underlying disease, including open cutaneous ulcers that could predispose the subject to infections. * immunodeficiency syndromes including felty syndrome or large granular lymphocyte syndrome. * active tuberculosis (tb) or a history of tb, or findings consistent with previous exposure to tb on a chest x-ray (cxr). investigators must follow china's guidelines for appropriate screening and treatment of tb. * history of hypersensitivity to any of the ingredients in either preparation.

Keywords: rheumatoid arthritis ankylosing spondylitis observational study
early, objective detection of autism.

Conditions: Autism Spectrum Disorder

Summary: 1- to test the hypothesis that using the sensodetect brainstem evoked response audiometry (bera) technology may be an effective support tool for pediatricians to detect autism.

this study will be conducted through two phases: phase i: a case-control study. this will be done at princess noura university/ king abdullah abdulaziz university hospital, riyadh, kingdom of saudi arabia from january 2024 to january 2027. the sensodetect bera technology previously described8,9,13,14 will be used in all parts of the study in the following way: all recruited participants are to be tested using sensodetect's patented technology. all tests shall be performed in a quiet and darkened room. participants will be asked to comfortably sit in an armchair in a resting position (part 1 only). surface electrodes will then be attached to the skin over the mastoid bones behind the left and right ear, with a ground electrode on one arm. two reference electrodes will also be placed on the forehead. before each test session, the procedure shall be fully explained to the test subject or parents. the subjects will then be instructed to relax with their eyes closed and are permitted to fall asleep (with modifications in part 3). the test will require no active participation other than sound stimulation. the subjects will be tested one at a time, and the duration of the testing procedure will be 15 min. the method is based on an electrophysiological test battery that emits 1024 click sounds divided into 4 sessions for 14 minutes. the data analysis software uses advanced mathematical algorithms and artificial intelligence (ai) to analyze and distinguish the patient's markers and compare them with diagnostic and non-diagnostic groups. bera is ce and mdd (mdd stands for medical device directive and is an approval for the device to be used under european law) approved. sensodetect holds the iso standard under medical technical products 13485:2016. after the test is completed, the result will be sent for analysis using sensodetect's analytical software (sensolytics). the ai classification model used for analyzing traits and predicting diagnosis is gaussian naïve bayes.

Eligibility criteria:
phase i: inclusion criteria: - all patients attending the clinic of autism. exclusion criteria: * hearing impairment * down syndrome * cerebral palsy * significant brain damage intellectual disability.

Keywords: abr (auditory brainstem response)
sphenoorbital meningioma management.

Conditions: Brain Meningioma

Summary: investigators will discuss the different surgical techniques for removal of spheno_orbital meningiomas with proptosis.investigators also will follow up the patient to know the outcome of removal of these tumours.


Eligibility criteria:
inclusion criteria: * all patients who have spheno_orbital meningioma with proptosis and candidate for surgery. exclusion criteria: * all patients have proptosis caused by other lesions than spheno_orbital meningioma.
p wave and qt dispersion in psoriasis

Conditions: Arrhytmia in Psoriasis

Summary: background: several reports have demonstrated an association between psoriasis and cardiovascular diseases. p wave dispersion (pwd) is the most important electrocardiographic (ecg) markers used to evaluate the risk of atrial arrhythmias. qt dispersion (qtd) can be used to assess homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias. aim: to search pwd and qtd in patients with psoriasis. methods: ninety-four outpatient psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ecg and transthoracic echocardiography. severity of the psoriasis was evaluated by psoriasis area and severity index (pasi).

ninety-four outpatient psoriasis patients and 51 healthy people were included in the study. patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded. diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy. severity of the psoriasis was evaluated by psoriasis area and severity index (pasi). patients were evaluated by physical examination, 12-lead electrocardiography and transthoracic echocardiography.

Eligibility criteria:
patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded.
efficacy of acupuncture for chronic low back pain

Conditions: Low Back Pain

Summary: this is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms.

this is a 4-arm multi-site randomized controlled trial to clarify the extent to which various types of acupuncture needling can diminish the effect of chronic low back pain on patient functioning and symptoms. reviews have noted the poor quality of research in this area and urged that scientifically rigorous studies be conducted. recent higher quality trials suggest acupuncture is a promising treatment for back pain. this study directly addresses methodological shortcomings that have plagued previous studies. a total of 640 subjects (160 per arm) with low back pain lasting at least 3 months will be recruited from group model hmos in seattle, wa and oakland, ca. they will be randomized to one of three different methods of stimulation of acupuncture or to continue usual medical care. ten treatments will be provided over 7 weeks. the primary outcomes, dysfunction and bothersomeness of low back pain, will be measured at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment. analysis of covariance within an intention-to-treat context will be used to analyze the data. because chronic back pain is a major public health problem and the top reason patients seek acupuncture treatment, a clear, unambiguous assessment is critical for making informed decisions about whether acupuncture should be included as part of conventional care for back pain or covered by insurance. results of this study will provide the clearest evidence to date about the value of acupuncture needling as a treatment for chronic low back pain.

Eligibility criteria:
inclusion criteria: * diagnosis of low back pain including lumbago, unspecified backache, sprains and strains of sacroiliac, lumbar, sacral, or unspecified regions of the spine * back pain must be of at least 3 months duration and rated at least 3 on a symptom bothersomeness scale exclusion criteria: * non-mechanical causes or potential causes of low back pain (i.e. sciatica, underlying systemic or visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer or unexplained weight loss, recent vertebral fracture) * previous treatment with acupuncture * inappropriate candidate for acupuncture (i.e. severe clotting disorders or on anticoagulant medication, heart pacemakers) * characteristics complicating the interpretation of the findings (severe or progressive neurologic deficits, back surgery within the prior three years, planning to seek other treatment for back pain) * characteristics related to ability to complete the study protocol (unable to speak english, plans to move out of town)

Keywords: low back pain acupuncture
asthma control through telemedicine

Conditions: Asthmatic Patients

Summary: the purpose of this research study is to evaluate the impact of pharmacist led educational interventions on asthmatic patients, and also determine their medication adherence. pharmacist's intervention aims to answer: 1. how a pharmacist intervention program impact medication adherence in persistent asthma? 2. to assess how pharmacist led educational intervention like patients' counseling and medication reminders through telemedicine have an impact on patient's asthma control? 3. which mode of communication (verbal instructions, videos and pamphlets) for the patient counselling is most beneficial for the patients in asthma control.

this is a randomized, pharmacist-led, two-group, longitudinal descriptive interventional study performed through in person (public and private hospitals) and telecommunication (whatsapp, network calls and messaging). the investigator will use snowball method to approach patients through telecommunication. recruited patients will be randomly divided into two groups: the control and the experimental group. the control group will not receive any intervention, and experimental group will receive special counseling about persistent asthma, it's medications and medical devices, their appropriate use, and side effects. using telemedicine as message and call reminders to increase medication adherence and improve their asthmatic condition. the intervention will be conducted for one month on the experimental group according to the recruitment date and time of the patients. pre-validated questionnaires will be used for the assessment 1. the adherence to asthma medication questionnaire (aamq-13). 2. asthma control test tm (act).

Eligibility criteria:
inclusion criteria: * age above 11 years. * persistent asthma patient. * patients taking medications and inhaler. * patient who will consent for the study. * patient with basic telecommunication facility. * patient who responded to messages and calls. exclusion criteria: * patients who will refuse to participate in study will not be included. * irresponsive patients to messages and calls

Keywords: asthma telemedicine pharmacist
a volumetric nomogram for height, weight, and intra abdominal volume

Conditions: Laparoscopy

Summary: this is a prospective study to collect a nomogram of intra-abdominal volume correlated with height and weight for o\&g patients undergoing minimally invasive surgery.

this is a prospective study from the date of approval of the study for a period of 24 months. the potential participants are from o\&g department who will be undergoing laparoscopy the participant's height, weight, and total volume of carbon dioxide gas infused into the abdomen are collected from cpss to create a standard operative pneumoperitoneum of 18mmhg for all patients undergoing laparoscopic procedures. patients with an abdomino-pelvic mass, or pelvic masses larger than 12 weeks size, or assessed to have an abdominal mass are excluded. pregnant and/or breast feeding women are also excluded. specific patient identifiers will not be collected into the data collection and are not necessary to the study or to achieving to the objective of the study. therefore data will not contain any identifiers.

Eligibility criteria:
inclusion criteria: * o\&g patients that are undergoing laparoscopic surgery. exclusion criteria: * patients with an abdomino-pelvic mass * patients with pelvic masses larger than 12 weeks size * patients assessed to have an abdominal mass * pregnant and/or breast feeding women
a clinical trial assessing efficacy and safety of sunitinib and exemestane in patients with er [estrogen receptor] + and/or pgr [progesterone receptor] + breast cancer

Conditions: Breast Neoplasms

Summary: to assess progression-free survival at the combination dose determined in the phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

the trial was terminated prematurely on august 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. there were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease * postmenopausal * ecog \[eastern cooperative oncology group\] \</=1 * evaluable(e.g bone only disease allowed) and measurable disease \[recist (response evaluation criterion in solid tumors)\] exclusion criteria: * her2 \[human epidermal growth factor receptor 2\] positive disease not previously treated with herceptin * any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting * radiation therapy within 2 weeks of first study treatment
risk factors for persistent postural-perceptual dizziness development

Conditions: Dizziness

Summary: the primary aim of this study is to determine whether the prevalence of neuroticism, anxiety and body vigilance is higher in patients diagnosed with pppd compared to those who suffered a vestibular insult but did not develop pppd and healthy controls. an increased prevalence of one or more of these factors may identify them as risk factors in the development of pppd. the secondary aim is to understand how pppd affects quality of life.

the diagnosis persistent postural-perceptual dizziness (pppd) entered the 11th edition of the world health organization's international classification of diseases (icd-11 beta draft) in 2015 following a consensus document on its diagnostic criteria created by the behavioral subcommittee of the committee for the classification of vestibular disorders of the bárány society (ccbs) between 2010 and 2014. the icd-11 describes it as follows: "persistent non-vertiginous dizziness, unsteadiness, or both lasting three months or more. symptoms are present most days, often increasing throughout the day, but may wax and wane. momentary flares may occur spontaneously or with sudden movement. affected individuals feel worst when upright, exposed to moving or complex visual stimuli, and during active or passive head motion. these situations may not be equally provocative. typically, the disorder follows occurrences of acute or episodic vestibular or balance-related problems, but may follow non-vestibular insults as well. symptoms may begin intermittently, and then consolidate. gradual onset is uncommon." in a previous systematic review of the literature, the authors discuss the pathophysiology and management of pppd, including certain psychological risk factors. anxiety has been suggested to play a pivotal role in the maladaptation cycle of pppd in part by increasing body vigilance and both neuroticism and a pre-existing anxiety disorder have been suggested as predisposing factors for the onset of this maladaptation cycle. such risk factors may allow the prediction of who might be at risk of developing pppd after an acute vestibular injury and thus benefit from early treatment. as pppd is a relatively new diagnosis, to date there is no study that comprehensively confirms the prevalence of anxiety, neuroticism and/or increased body vigilance in sufferers specifically. it is important to determine this in order to guide further research into treating and potentially preventing its onset.

Eligibility criteria:
inclusion criteria * must have diagnosis of pppd based on the ccbs criteria * aged under 18 years old * able to provide informed consent exclusion criteria * no confirmed/firm diagnosis of pppd * aged \<18 years old * unable to provide informed consent * current clinically significant illness that could confound the study results
comparison between vaginal pessary and progestogen in twin pregnancy with short cervical length

Conditions: Preterm Birth

Summary: a randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.

this is a randomized controlled trial to compare women with twin pregnancies and diagnosed with asymptomatic short cervical length. two types of interventions will be compared i.e vaginal progestogen and vaginal pessary.

Eligibility criteria:
inclusion criteria: * all twin pregnancies * cervical length less than 30mm exclusion criteria: * twin to twin transfusion syndrome * stillbirth * congenital anomaly in one of the fetuses * previous cervical trauma or surgery * cervical cerclage in current pregnancy * premature labour with or without rupture of membranes * severe vaginal discharge * acute vaginitis or cervicitis

Keywords: twin vaginal pessary vaginal progestogen short cervix
addressing the role of nutrition education & health literacy in diabetes care

Conditions: Diabetes

Summary: this study examines the impact of certified diabetes education, and the role of different educational approaches to medical nutrition therapy. in addition the role of patient health literacy level is assessed

150 patients with type 2 diabetes with most recent a1c\>7% will be enrolled. patients are randomized to three arms: arm 1 includes 3 individualized visits with an rd-cde focused on a modified plate method for nutrition therapy, arm 2 includes 3 individualized visits with an rd-cde focused on carb counting for nutrition therapy, and arm 3 focuses on general diabetes education and health promotion. education sessions will be administered over a 4-6 week period. patients will be assessed at baseline, 3 and 6 month follow-up. primary outcome is a1c.

Eligibility criteria:
inclusion criteria: * most recent a1c \>7 * type 2 diabetes * receiving primary care * not currently in the diabetes improvement program * no plans to refer to diabetes improvement program in the next 6 mos exclusion criteria: * significant dementia or psychosis

Keywords: diabetes education health literacy
effects of mill's manipulation along with muscle energy technique in lateral epicondylitis

Conditions: Lateral Epicondylitis

Summary: the effects of muscle energy technique intervention have been investigated in recent studies in lateral epicondylitis. some studies have been conducted about mills manipulation and muscle energy technique but according to the literature review there is no study exist to determine the effects of mill's manipulation along with muscle energy technique in lateral epicondylitis. because of this reason, further research required to find out the effects of mill's manipulation along with muscle energy technique in pain, range of motion and disability in lateral epicondylitis. so the aim of the study is to determine whether these techniques are effective and should be incorporated frequently in a clinical setting in relation to the conventional therapy. this study will help the clinician for the identification of the better and quick treatment regime which will have no adverse effects and risks and making them more effective, efficient for the patient with lateral epicondylitis.


Eligibility criteria:
inclusion criteria: * patient that have been diagnosed with lateral epicondylitis (pain and point tenderness over lateral epicondyle and / or 1-2cm distal to epicondyle). * both male and female patients between the age group of 18 to 45 years old. * any of the following tests positive: cozen test, mills, maudsley. exclusion criteria: * history of rheumatic arthritis * history of elbow instability * history of former fracture of the elbow * history of cervical radiculopathy. * history of radial tunnel syndrome (patient with rts will report pain over lateral forearm approximately 3 to 5 cm distal to the elbow worsens with rotational movements of the forearm). * history of any neoplasia * any congenital or acquired deformity of upper limb. * history of trauma. * history of corticosteroid injection within 6 months. * individual having symptoms of vertigo